Narcotics research, rehabilitation, and treatment. Hearings, Ninety ...

400Mr. Perito. Were you getting data from the Dole-Nyswanderprogram back in 1963, 1964, when they first started experimentation?Dr. Gardner. No. At that time there was no IND procedure forthis and methadone for the maintenance treatment of heroin addictionwas not specifically precluded or guided by any regulations.Mr. Perito. Do you now have proper manpower in your agency toinvestigate the 277 methadone maintenance programs and protocolsso that your Agency is able to make an informed judgment as to thesafety and efficacy of such treatment programs?Dr. Edwards. Manpower, as far as we are concerned, is a veryscare commodity. Our inspectors in the field are involved in the food,product safety, and drug fields of activity. So the real answer to yourquestion is no, but we have given this a very high priority in theagency and are expanding special effort in this area.We consider this one of the major problems that we are confronted\\dth and have diverted a lot of our manpower into this ])rogram. Imust also say, however, that it takes a person with special training toreally get involved in these programs, in the inspect programs suchas this. Consequently, we are in the process of training some of ourpeople in the inspectional techniques necessary to inspect theseprograms and to give us the kind of information we need atheadquarters.Mr. Perito. Do you know how many people FBNDD have assignedto work with you in conjunction with this effort?Dr. Edwards. Not specifically.Dr. Jennings. No, sir; but to backtrack a little bit to explain someof the background that Dr. Gardner referred to, until recently aninvestigator of any drug was entitled to begin his investigations assoon as he had filed with us his notice that he intended to do so. As amatter of fact, he was entitled to begin the investigations as soon ashe had mailed in his application.Mr. Perito. In other words, a licensed physician could startimmediately without getting your prior approval?Dr. Jennings. That is right. About a year ago, for reasons notdh"ectly related to methadone but to other investigational drugs, wepromulgated a regulation that requu^ed a 30-day waiting periodbefore he could begin his investigations.When the methadone regulations went into effect in April, theycontained still another safeguard. That is, that there would have to beprior approval, not only by the Food and Drug Administration butby the Bureau of Narcotics and Dangerous Drugs before the studiescould be instituted.We have now been informed that the Bureau of Narcotics andDangerous Drugs is going to make an onsite investigation of eachinvestigator prior to giving their required approval to the investigationalnew drug investigation. The studies that exist now were notsubjected to this sort of scrutiny. Prior to April 2, they were approvedby the Food and Drug Administration in the manner then part of ourprocedure; that is, the investigator's qualifications were examined,his protocol was reviewed, and if there was nothing obvious thatwould prevent the application trom being approved, it was permittedto go into effect in accord with the then current procedure, that is, a30-day waiting period.